Clinical Supply Coordinator - Dechra Pharmaceuticals PLC
Portland, ME 04101
About the Job
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business
The Opportunity
The primary function of the Scientist, Clinical Supply is to manage all aspects of study drug shipments, labelling, and reconciliation, and to provide study support for clinical and non-clinical studies conducted by Dechra Product Development. This position, Scientist, Clinical Supply will serve the role of the Clinical Supply Coordinator and will work closely with the study teams to ensure that all aspects of clinical supply (logistics and distribution of study drug and other materials) are planned and executed to the timelines in the project plan. The Scientist will manage relationships with clinical supply CROs and oversee the work they perform.
May function as a Monitor on clinical and non-clinical studies, as required. Additional responsibilities may be added based on business need.
Main Responsibilities
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
Clinical Supply Coordination
- Advise Product Development personnel on importation/exportation requirements for study drug/materials
- Draft necessary documents required for importing/exporting study drug and supplies for clinical and non-clinical studies, coordinate review and finalization of documents.
- Work with Regulatory Affairs to ensure regulatory notifications for study drug shipments are submitted in a timely manner. This includes imports, exports, and domestic shipments
- Coordinate shipments with appropriate couriers
- Collaborate with study teams on the content and finalization of the clinical supply plan (may include labelling, masking, logistics, etc.)
- Oversee labelling of study materials by CRO in accordance with the clinical supply plan
- Serve as main point of contact between Dechra personnel and relevant CROs, couriers, manufacturers, etc.
- Maintain relationships with suppliers, CROs, and couriers and ensure that necessary contracts are kept up to date
Clinical Study Coordination and Monitoring
- Maintenance of central files including organization and filing of documents on a regular basis including shipments and archiving, as needed
- Coordination and QC of data
- Creation/QC/tracking of study and laboratory supplies
- Assist monitors with review of data for compliance
- Serve as Monitor on clinical studies as requested and serve as point of contact between Dechra and study sites
- Assist with review and QC of study documentation (e.g. protocols, tables, final study reports)
- Support project and Clinical Trial Manager as needed
Non-Clinical Study Coordination and Monitoring
- Assist in managing contracted test facilities (CROs) in planning, conducting, and reporting of non-clinical studies
- Monitor study procedures, review data, and review reports to ensure accuracy and quality
- Assist in research and design of non-clinical studies
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:
- Minimum of 5 years’ experience in pharmaceutical development and/or scientific research experience
- Experience in managing vendor relationships and external logistics providers
- Knowledge of regulatory requirements for clinical trials
- Critical thinking to assess areas for improvement and initiative to bring forward these ideas driving efficiency in business operations
- Self-starter, quick-learner, independent, proactive, and self-motivated with consistent attention to detail
- Strong analytical and organizational skills with ability to handle multiple tasks and prioritize based on guidance from management
- Ability to communicate effectively with strong written/verbal skills
- Demonstrate collaboration and communication skills in a team environment, share knowledge, influence best practices, and coordinate workflow
Desirable
- Experience in managing vendor relationships and external logistics providers
- Knowledge of regulatory requirements for clinical trials, especially in animal health
- Hands-on experience in inventory management, packaging, and distribution of clinical supplies
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.